Status:
RECRUITING
Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy
Lead Sponsor:
Emory University
Collaborating Sponsors:
Lunair Medical
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a disorder where a person has recurrent choking episodes during sleep. Surgery can treat OSA and drug induced sleep endoscopy (DISE) is a procedure that surgeons use t...
Detailed Description
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent choking episodes during sleep. OSA affects over 25 million Americans and is associated with increased risks of hypertensio...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 yrs) willing and capable of providing informed consent
- Obstructive sleep apnea (AHI ≥ 5 events/hour)
- Must be willing and able to provide informed consent to participate in the study.
- Interested in surgical treatments of OSA and have consented for a DISE procedure as part of their routine clinical evaluation.
- Patients are evaluated and cleared by anesthesia prior to the procedure.
Exclusion
- No significant uncontrolled medical co-morbidities (e.g., uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD).
- Any medical comorbidity that would prevent the patient from receiving anesthesia or having surgery
- Inability to tolerate negative pressure ventilator or perform PFT (i.e. claustrophobia)
- No incapacitating disability that interferes with execution of the protocol
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05350332
Start Date
June 30 2022
End Date
June 1 2026
Last Update
October 20 2025
Active Locations (1)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308